Ranbaxy-Cefaclor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefaclor monohydrate 535mg equivalent to cefaclor 500 mg (plus 2% overage.)

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Cefaclor monohydrate 535 mg (=cefaclor 500 mg; plus 2% overage.)

Dosage:

500 mg

Pharmaceutical form:

Capsule

Composition:

Active: Cefaclor monohydrate 535mg equivalent to cefaclor 500 mg (plus 2% overage.) Excipient: Brilliant blue FCF Carmoisine Colloidal silicon dioxide Croscarmellose sodium Gelatin   Iron oxide black Magnesium stearate Methyl hydroxybenzoate   Ponceau 4R Pregelatinised maize starch Propyl hydroxybenzoate   Titanium dioxide  

Units in package:

Blister pack, 3x7 caps, 21 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Parabolic Drugs Limited

Product summary:

Package - Contents - Shelf Life: Blister pack, 3x7 caps - 21 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 100 capsules - 100 - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1997-06-26

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ranbaxy-Cefaclor 250 mg capsules
Ranbaxy-Cefaclor 500 mg capsules
Ranbaxy-Cefaclor 125 mg/5 mL granules for oral suspension
Ranbaxy-Cefaclor 250 mg/5 mL granules for oral suspension
Ranbaxy-Cefaclor SR 375 mg modified release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ranbaxy-Cefaclor 250 mg capsule contains cefaclor monohydrate
267.5 mg (equivalent to
cefaclor 250 mg).
Each Ranbaxy-Cefaclor 500 mg capsule contains cefaclor monohydrate 535
mg (equivalent to
cefaclor 500 mg).
Each mL of Ranbaxy-Cefaclor 125 mg/5 mL oral suspension contains
cefaclor monohydrate 27.8
mg (equivalent to cefaclor 25 mg).
Each mL of Ranbaxy-Cefaclor 250 mg/5 mL oral suspension contains
cefaclor monohydrate 55.6
mg (equivalent to cefaclor 50 mg).
Each Ranbaxy-Cefaclor SR 375 mg modified release tablet contains
cefaclor 405.27 mg
(equivalent to cefaclor 375 mg).
EXCIPIENT(S) WITH KNOWN EFFECT
Ranbaxy-Cefaclor oral suspension contains sucrose.
Ranbaxy-Cefaclor modified release tablet contains lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule 250 mg: Purple/white size 2 gelatine capsule imprinted with
“CEFACLOR 250’ on both
the cap and body of the capsule.
Capsule 500 mg: Purple/grey size OEL gelatine capsule imprinted with
“CEFACLOR 500’ on both
the cap and body of the capsule.
Oral suspension 125 mg/5 ml: White to off-white granular powder, which
upon reconstitution
with water forms a red strawberry, flavoured suspension with a sweet
taste.
Oral suspension 250 mg/5 ml: White to off-white granular powder, which
upon reconstitution
with water forms a red strawberry, flavoured suspension with a sweet
taste.
Modified release tablets: Capsule shaped, biconvex, unscored, blue
film-coated tablet, imprinted
with "Cefaclor CD 375mg" in black.
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4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cefaclor is indicated in the treatment of the following infections
when caused by susceptible
strains of the designated micro-organi